Recruiting

VDO with Dental Splints

Sponsor:

Boston University

Code:

NCT06974591

Conditions

Posture

Eligibility Criteria

Sex: All

Age: 30 - 65

Healthy Volunteers: Not accepted

Interventions

Dental splints

Dentures

Study Details

Brief summary:

A connection of the stomatognathic system \[an anatomical system comprising the teeth, jaws, and associated soft tissues\] to postural control has been suggested in the literature. This research will investigate how occlusion can impact postural response, disorder, and rehabilitation by examining how modifications in the vertical dimension of occlusion (VDO) influence balance and gait.

Although it is currently unclear which or how restorative approaches cause postural disturbances, changes in several occlusal factors, i.e. VDO, Angle's class, crossbite and others have been suggested to manifest clearly into an altered stability, which could have a significant effect on the quality of life, especially in the elderly.

The present study aims to identify the degree to which specific interventions in oral cavity affect the stability and gait patterns of patients, This will b achieved by either:

  • The use of dental splints (fully certified devices)
  • The use of the subjects' own dentures

A direct correlation of postural perturbations and VDO, would essentially void the necessity to evaluate specific interventions (e.g. different types of restorations) independently and allow clinicians to assess a potential effect on their patients' stability and gait based on pre- to post- treatment VDO.

Conditions

Posture

Study ID

NCT06974591

Start date

Nov 17, 2025

Status verified date

Dec, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria for Group A

  • 30-45 years old
  • Physically and cognitively healthy (able to easily walk without assistance)
  • Possessing a complete set of teeth (either natural or restored with crowns)
  • Classified as Class I malocclusion according to Angle's criteria.

Inclusion criteria for Group B

  • 50-65 years old
  • Physically and cognitively healthy (able to easily walk without assistance)
  • Fully edentulous
  • Wear complete dentures

Exclusion Criteria:

  • Parkinson's Disease
  • Morbid obesity i.e. BMI values exceeding 40, calculated based on body weight and height requested over the phone or during the visit
  • Occlusion altered due to a non-physiological condition i.e. trauma or pathology
  • Active temporomandibular joint disorder
  • Pregnancy, as pregnancy-related physiological changes could influence the study's balance and gait measurements. This exclusion will be based on self-report during the screening process, and no additional testing will be conducted.
  • Any other condition that in the opinion of the study researchers has potential to impact balance or gait

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Group A- dental splints

Participants in this group will be adults aged 30-45 with complete dentition and Class I malocclusion. Participants must have a complete set of teeth, either natural or with crowns, ensuring no teeth are missing.

active comparator: Group B- dentures

Participants in this group will be older adults aged 50-65 who are edentulous (without natural teeth) and wear full dentures.

Interventions

Dental splints

Each participant will receive six custom-made dental splints to incrementally increase their VDO. These splints will alter the VDO in increments from 5 to 30 mm, specifically: 5, 10, 15, 20, 25, and 30 mm.

Dentures

Participants in this group will participate in balance and gait testing both with and without their dentures to examine how the presence or absence of dentures affects postural stability and movement.

Primary outcome measure

  • Center of pressure [ Time Frame: 60-90 minutes ]
  • Postural sway [ Time Frame: 60-90 minutes ]
  • Stride length [ Time Frame: 60-90 minutes ]
  • Step width [ Time Frame: 60-90 minutes ]
  • Gait velocity [ Time Frame: 60-90 minutes ]
  • Muscle activation [ Time Frame: 60-90 minutes ]

Central Contacts and Locations

Central contacts

Alexandros Tsouknidas, PhD

617-358-8777atsouk@bu.edu

Locations

Goldman School of Dental Medicine, Boston University

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Alexandros Tsouknidas, PhD

617-358-8777atsouk@bu.edu

More Information

Sponsor

Boston University

Last update posted

Dec 4, 2025

Last verified

Dec, 2025

Keywords

  • Dental splints
  • Dentures
  • Vertical Dimension of Occlusion
  • Temporomandibular Joint Disorders
  • Balance
  • Gait

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston University on 2025-12-04.